C6 4-0 Ch Gut 18"/45cm 558BRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848782009190), received between Nov 19, 2021 and Nov 19, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2021Detachment of Device or Device Component

  NEEDLE DETACHED TWICE. FIRST INCIDENT THE NEEDLE REMAINED GRASPED WITH THE HEMOSTAT AND REMOVED/DISCARDED. NO INJURY OR INTERVENTION. SECOND EVENT THE NEEDLE COULD NOT BE LOCATED. THE DENTIST PERFORMED A CHEST X-RAY BUT NO NEEDLE WAS FOUND. THE OFFICE WAS SEARCHED, NEEDLE NOT FOUND. THE DENTIST THOUGHT NEEDLE MAY HAVE BEEN SUCKED UP BY THE HIGH VOLUME SUCTION. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12849601 ↗